A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoger Strair
About this trial
Purpose/Specific Aims
The study will determine if there is a reduction in malignant cell burden when patients with relapsed and/or refractory acute myeloid leukemia (AML) or multiple myeloma (MM) consume tea made from the dried leaves of Annona muricata (Soursop).
The study goal is to determine the safety and anti-neoplastic efficacy of Annona muricata tea when taken in escalating frequency over a period of 21 days by patients with relapsed/refractory AML or MM for whom there are no standard therapeutic options.
Eligibility criteria
Qualifiers
Patients with relapsed or refractory AML or MM not on any anti-neoplastic therapy who have exhausted all therapies and have no available therapy.
For AML: Quantifiable leukemia cells in blood (patients without circulating AML blasts may participate if they agree to baseline and post-treatment bone marrow testing)
For MM: Quantifiable M component (SPEP) or serum free light chain abnormality (ratio greater than 10)
ECOG PS 0,1, or 2
Disqualifiers
Inability to understand the study procedures
Inability to understand the consent form --Pregnancy, breastfeeding, or inability or unwillingness to use effective contraception
Trial design
Treatments tested in this trial
- Soursop tea
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Roger Strair
Lead sponsor
The Cooper Health System
Sponsor institution
Source ClinicalTrials.gov